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Congress continues to look at ways to stimulate more research on anti-infectives. The list of potential incentives gets longer each time another drug category wins a new form of incentive. None of the ideas has succeeded yet in coalescing a political consensus; but potential legislative vehicles are out there. . . . [MORE . . .]

An FDA advisory committee rejects the idea of adding niacin to abusable drugs in order to provoke a flushing reaction and thereby discourage abuse. King and Acura respond by flushing the idea itself and focusing on physical barriers to abusability. For other sponsors, King's failed attempt to change FDA's mind looks like a study in what not to do. . . . [MORE . . .]

Early on in the committee discussion of Acurox, FDA made its feelings about the product clear. Here is a transcript of the exchange between two committee members and two FDA officials on the key question about the King application: what exactly should be required to allow inclusion of niacin in the formulation with the goal of provoking adverse effects in abusers of immediate release oxycodone. . . . [MORE . . .]

When King Pharmaceuticals Inc. Chief Scientific Officer Eric Carter concluded his presentation during the April 22 advisory committee review of the novel oxycodone/niacin formulation Remoxy, he sounded almost like an attorney making a closing argument before a jury. . . . [MORE . . .]

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Is FDA trying effectively to ban the practice of providing disease awareness information in promotoional materials? A recent letter to Auxilium on promotional materials for the company's drug for Dupuytren Disease (Xiaflex) suggests FDA is still looking closely at how companies describe disease states compared to a product's labeled indications. . . . [MORE . . .]

Drug sponsors are finding little to like about FDA's transparency initiative-especially proposals that would allow the agency to disclose more about products still in development. But given the public interest in greater transparency-and FDA's interest in avoiding another Avandia-industry needs to decide whether this is a fight worth having. . . . [MORE . . .]

While FDA's proposed transparency initiative is still under discussion, there are signs that the agency is already taking a more liberal view of its disclosure polices. InterMune's pirfenidone is a case in point. . . . [MORE . . .]

The pharmaceutical industry's 50% donut hole discount worked out exactly as planned in the context of shaping the health care reform debate. The implementation of the new program is a different story. The program created by CMS doesn't look anything like industry would have hoped-but manufacturers have no choice but to play by CMS' rules, and try to make it work for them anyway. . . . [MORE . . .]

President Obama hosted a “town hall” discussion on health care reform and senior citizens June 8. Not surprisingly, the plan to fill in the Medicare Part D donut hole was touched on several times. If manufacturers expected credit for giving a 50% discount, they didn’t get it. They did, however, hear some unwelcome discussion of ideas like price negotiation. On the other hand, the President stressed the role of health care reform in assuring access to drugs. Excerpts from the official White House transcript. . . . [MORE . . .]

It appeared as though the controversy over the level of efficacy and benefit from the prostate cancer immunotherapy Provenge ended when the drug was approved by FDA at the end of April. The FDA approval may have just been the halfway point in the product's route through government agencies to the commercial market. Now Medicare is questioning whether the government should pay for the new therapy. The CMS decision is just as important to the biopharmaceutical industry as it is to Dendreon. . . . [MORE . . .]

Senate Finance Committee minority staff investigator Paul Thacker has been a leading figure behind the effort to make public the recipients of pharma funding and grants. Here are his thoughts from a recent conference on the future of industry funded CME. . . . [MORE . . .]